MAUDE Adverse Event Report: OWEN MUMFORD USA, INC. AUTOJECT; INTRODUCER, SYRINGE NEEDLE

Device Problems Device Slipped (1584); Failure to Infuse (2340)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2020

Event Type  malfunction  

Event Description

Pt called to place an order and reported that 2 syringes would not inject once put in the auto-injector on 2 different occasions in january.Once she removed them, the plungers fell out.No adverse events occurred since she had other syringes to use.Reported (b)(6) by pt/caregiver.

• Brand Name: AUTOJECT
• Type of Device: INTRODUCER, SYRINGE NEEDLE
• Manufacturer (Section D): OWEN MUMFORD USA, INC.
• MDR Report Key: 9799899
• MDR Text Key: 182625059
• Report Number: MW5093556
• Device Sequence Number: 2
• Product Code: KZH
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 64 YR